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Therapeutic Target Validation in Mental Health Call - call for proposals

Introduction

The Therapeutic Target Validation in Mental Health (TTV-MH) Call will support programmatic, collaborative awards that accelerate research and development in order to provide much-needed and more effective therapies and early, preventative interventions for mental health problems. TTV-MH awards will require collaborative approaches that can draw on expertise from multiple disciplines, including mental health, cognitive neuroscience, psychiatry, psychology, pharmacology, drug discovery, chemistry, genomics, medical imaging and/or biomarker development. Awards in this call will be made in the range from £1 million to £1.5 million (MRC contribution) for a duration of up to five years. The MRC will make up to £5 million available for this call and expects to support around four to five awards. This call has an initial Expression of Interest stage followed by the invited submission of full applications.

Contents:

Background

Mental health problems have a major impact on the UK’s health, wealth and wellbeing. An estimated one in six of us is affected by mental illness each year in the UK and it costs the economy £70-100 billion annually as a consequence of lost productivity, time off work, social benefits and healthcare. Mental health and illness stem from a multidimensional interplay of biological, psychological, social and environmental factors which influence risk and resilience to illness and response to treatment. A key priority identified in the MRC Strategy for Lifelong Mental Health Research is to “accelerate research and development to provide much-needed and better pharmaceutical and non-pharmaceutical therapies (including, but not exclusive to, psychological, behavioural, cognitive and digital) and early, preventative interventions for mental illness.”

Drug development in neurosciences and mental health has declined over the last decades, driven at least in part by a high failure rate in translation of preclinical efficacy findings. Late failures may be attributable to a lack of understanding of the causative biological mechanisms and inadequate validation of the biological target in human studies. There is a need to improve academic-industry connectivity and awareness, so that the outputs of discovery research include the requisites of the downstream development pipelines. Industry may in turn be able to reengage with neuroscience/mental health research areas if the risk of moving from phase 2 to costlier phase 3 trials could be reduced, for example through the provision of deeper, more robust mechanistic foundations, or evidence of meaningful levels of target engagement and/or the provision of tools required to show this.

A multidisciplinary approach is needed to enhance the understanding of targets in mental health; develop new discovery platforms, reagents and tools; develop innovative new treatment paradigms; and revisit, repurpose or redesign the existing pharmaceutical and psychological therapy options.

Aim

TTV-MH awards will complement the wide range of mental health research supported by the MRC and will build on the UK’s excellent discovery research in mental health. This call will support multidisciplinary collaborations to develop innovative approaches and enable more effective biomarker development and target validation, leading towards the development of new therapeutic options in mental health.

Remit and scope

The MRC has made up to £5 million available for TTV-MH awards. Each award will provide an MRC contribution typically in the range of £1 million to £1.5 million over a duration of up to five years. Funded projects will be expected to network and share experience and best practice in therapeutic target discovery, identification, engagement, validation and exploitation.

TTV-MH awards can be used to fund the costs of multidisciplinary collaboration and research in the space between discovery science and the later stages of the development pipeline, and would include target development, qualification and validation, experimental medicine studies, and development of biomarkers. Awards will support research to prepare the way to applications for MRC’s Developmental Pathway Funding Scheme (DPFS), industry or other funding schemes. Applications to this call should not be suitable for funding through other MRC schemes.

Awards will be made at MRC’s standard FEC rate of 80%.

Proposals should aim to address one or more of the following challenges:

  • developing potential human targets for psychological or pharmacological intervention; including experimental medicine studies involving humans or preclinical studies utilising human tissue or human induced pluripotent stem cells (iPSCs). This could include building on recent developments in genetics, immunology, psychology and cognitive neuroscience in mental health research.
  • advancing knowledge of causative biological pathways and mechanisms; improving mechanistic understanding of new targets, increasing knowledge of the pathway or mechanistic context of a target
  • establishing or refining strategies for development of known targets, pathways and mechanisms, for example platform technologies for validation, data mining, genetics, brain banks, and back translation from clinical findings
  • stratification, resulting in better diagnosis or prescribing of therapeutic options, and a focus on symptom dimensions rather than diagnostic categories
  • target engagement; developing or validating reliable markers/biomarkers of target engagement that provide direct evidence that the targeted pathway was affected.

The scope of this call does not include:

  • novel discovery research without an existing foundation of knowledge (that has been funded by MRC or others)
  • full translational programmes developing or evaluating new interventions (see the MRC DPFS scheme)
  • studentships.

Therapeutic targets could be in any area of mental health, including conditions of child, adolescent and/or adult age onset and including all mental health disorders. Neurodegenerative disorders are not included within the scope of this call.

Due to the complex nature of target discovery and validation, and because a single research group or institution is unlikely to possess all the required skills and capabilities, we are looking to support effective collaborations that can demonstrate the relevant expertise to manage a complex programme of work. Successful proposals will include investigators from multiple research groups across relevant disciplines, which may include mental health, cognitive neuroscience, psychiatry, psychology, pharmacology, drug discovery, chemistry, genomics, medical imaging and/or biomarker development etc. TTV-MH awards are expected to support new networks and ways of working together, and collaborations between groups based at different research organisations are particularly encouraged. To enable productive and lasting collaborations, a small amount of funds may be directed towards collaboration forming activities.

Successful applications should show an awareness of the needs of industry, for example in the generation of suitable data packages for potential downstream development. Applicants are encouraged to explore how awards could be used to develop academic-industry interactions through collaboration with industrial partners, in accordance with MRC standard terms and conditions (see MICA guidelines).

Eligibility

For information on the eligibility of organisations and individuals to receive MRC funding, see the Guidance for applicants 'Who can apply'. Researchers can be the principal investigator on only one application but may act as a co-investigator on any number of applications.

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Key dates

Activity

Date*

Expression of Interest:

Call opens

1 May 2018

Deadline

24 July 2018, 16:00 GMT

Panel review, decision to invite

10 September 2018

Full application:

Opening

17 September 2018

Deadline

27 November 2018

Peer review and applicant response January 2019

Panel review and decisions

13 February 2019

*MRC aims to adhere to the key dates as published, however there may be exceptions where the dates may have to change due to board/panel member availability.

How to apply

The call process will be in two stages:

  • Expression of Interest
  • Full application.

Please note that the MRC reserves the right to amend the review process in the case of high demand.

Expression of Interest

Applicants should first submit an Expression of Interest (EoI). EoIs will be assessed by an expert panel and successful applicants will then be invited to submit a full application. Applicants invited to submit a full application will be eligible for a grant of up to £3,000 to support collaboration development during preparation of a full application (eligible costs would include travel, meeting and/or workshop expenses between research organisations; costs for activities within one organisation should be proportionate and justified).

The panel will assess EoIs against these criteria:

  • scientific excellence and fit to TTV-MH remit
  • strength of scientific rationale, including the proposed target/pathway
  • clinical need and likely translational impact
  • strategy and novelty of the research approach, including human relevance
  • multidisciplinarity of the research team, and the relevant expertise and skills of the team
  • intended outputs and outcomes, future plans for downstream development.

Assessment will also consider the MRC funding portfolio and current strategic priorities.

EoIs must be submitted using the TTV-MH EoI form, which is structured as follows:

  • project summary (title, summary, duration, estimated cost)
  • details of principal investigator and co-investigators
  • outline Case for Support, including:
    • nature and importance of the challenge that will be addressed
    • proposed approach, methods and techniques, research plan
    • collaboration details, roles and expertise, project management
    • outputs and plans for their future development, contribution towards development of UK expertise.

Completed EoI forms with any permitted attachments (see Attachments check list below) should be submitted as one complete PDF file via your research organisation’s administrative department by email to TTVMentalHealth@mrc.ukri.org by the deadline given in Key dates.

Supplementary data

Up to two pages of supplementary data may be included, for preliminary data, diagrams, Gantt charts etc.

CVs and list of publications

CVs should be a maximum of two sides of A4. The publications list should highlight relevant and recent publications and should be a maximum of one side of A4. Further details of CVs can be found in MRC’s Guidance for applicants.

Full applications

If successful at the EoI stage, applicants will submit full proposals which will be sent out for international peer review and assessed by a panel convened by MRC. This panel will make the final funding decisions. Full proposals will be assessed on the standard criteria for an MRC research grant, with a focus on:

  • the strategy and novelty of the research priority and approach
  • the case made for human relevance of the experimental techniques used, in particular the use of experimental medicine approaches involving human subjects; target validation in humans or human tissue
  • the completeness of the skills required within the multidisciplinary team, and plans and evidence of successful co-working
  • quality and skills of the research teams; collaborative, multidisciplinary nature
  • articulation of the potential outputs and downstream development plans (following on from this grant); engagement with the needs and requirements of patients, industry, relevant charities and health departments.

Additional grant conditions

In addition to the standard terms and conditions for grants, successful applicants will be expected to participate in networking activities involving all the awards funded under this call.

Applications involving industrial collaborators should follow the MICA process; completed and signed MICA forms will be required for full applications but are not required at the EoI stage.

Attachments check list

Please ensure you adhere to the requirements below when submitting your proposal. Any missing, over length or unnecessary attachments may result in your proposal being rejected.

Attachment

Page limits

Notes

CV

2 sides of A4

Mandatory (any number)

List of publications 1 side of A4 Mandatory (any number)

Supplementary data

2 sides of A4

Optional (one)

 

All attachments should use a sans-serif typeface (Arial or equivalent) and font size of 11pt.

Contacts

Specific queries about this funding scheme and application process should be directed to TTVMentalHealth@mrc.ukri.org

To discuss your application, please contact Dr Rachael Panizzo (rachael.panizzo@mrc.ukri.org; Programme Manager, Mental Health) or Dr Adam Babbs (adam.babbs@mrc.ukri.org; Programme Manager, Developmental Pathway Funding Scheme (DPFS)).

EoIs should be submitted by your research organisation’s administrative department by email to TTVMentalHealth@mrc.ukri.org

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